Atherosclerotic cardiovascular disease remains a major cause of premature death and morbidity, in most regions of the world. Various transluminal, catheter-based interventional techniques have been used, or proposed for use, to dilate or otherwise treat atherosclerotic obstructions that occur in coronary and/or peripheral arteries. These therapies have traditionally focused on treating the disease intraluminally, or from “within” the vessel lumen.
The devices, systems and methods proposed in previous disclosures from which the present application claims priority introduce a new method of percutaneous revascularization wherein the cardiac veins may either be arterialized, or may be simply used as bypass grafts. Various percutaneous, transluminal techniques have thus been developed for bypassing obstructions in coronary or peripheral arteries through the use of the adjacent vein(s) as in situ bypass conduit(s); (e.g. using catheters to perform extra luminal procedures outside the diseased vessel lumen. In some instances, these procedures may be performed by a venous approach wherein a tissue penetrating catheter is inserted into a vein and the desired passageway or puncture is initially formed by facilitating the passage of a tissue penetrator (e.g., a flow of energy or an elongate penetration member) from a catheter, through the wall of the vein in which the catheter is positioned, and into a target location such as the lumen of an adjacent vessel (e.g. the artery). Alternatively, some of these procedures may be performed by an arterial approach wherein the catheter is inserted into an artery and the desired passageway or puncture is initially formed by facilitating the passage of a tissue penetrator (e.g., a flow of energy or elongate penetration member) from the catheter, through the wall of the artery in which the catheter is positioned, and into the target location such as the lumen of an adjacent vessel (e.g. a vein).
The present invention derives from and expands upon the previous disclosures with respect to stabilizing a tissue penetration catheter in a body lumen.
The prior art has included tissue penetrating catheters for uses other than those claimed in this patent application, but such prior art tissue penetrating catheters fail to include all of the elements required for optimal use in the methods of this invention or for precise targeting of the location at which the penetration tract is to be made. For example, U.S. Pat. No. 5,464,395 (Faxon et al.) discloses a catheter for delivering therapeutic and/or diagnostic agents to tissues surrounding a body passageway (e.g., the lumen of a blood vessel). The catheter devices disclosed by Faxon et al. generally comprise a catheter, a needle cannula that is able to be projected outboard of the catheter so as to deliver the desired agents to the tissue, and preferably one or more inflatable balloons useable to perform a balloon angioplasty procedure in addition to the injection of drugs or other therapeutic or diagnostic agents into tissues surrounding the vessel in which the catheter is positioned. However, the Faxon et al. device does not incorporate any means for precisely aiming its needle to a specific target location. Thus, while the Faxon et al. device may be useable to deliver drugs or other materials to relatively non-specific locations surrounding a vessel in which the catheter is positioned, its lack of sophisticated orientation and aiming apparatus renders it less than optimal for performing injections into specific or discrete target locations such as small anatomical structures, other blood vessels, etc.
Accordingly, there remains a need in the art for the development of new stabilized tissue penetrating catheters that can be used for revascularization, drug delivery, transluminal interstitial interventions and other procedures wherein it is desired to pass a tissue penetrator from a catheter, through the wall of a vessel (e.g, blood vessel or other body lumen) in which the catheter is positioned and to a target location (e.g., another blood vessel, a specific location within tissue, an organ, tumor or other anatomical target structure or lesion.